RRMM

Gracell Biotechnologies Announces FDA Clearance of IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Refractory Systemic Lupus Erythematosus

Retrieved on: 
Monday, November 27, 2023
Quality of life, Food, Autoimmune disease, Autoantibody, Immune system, IND, FDA, SLE, IIT, Tissue, BCMA, Society, Cancer, Pharmacokinetics, Standard of care, B cell, Neurotoxicity, NHL, RRMM, Patient, CD19, Safety, Vaccine

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared Gracell’s Investigational New Drug (IND) application, allowing the Company to initiate a Phase 1/2 clinical trial of FasTCAR-T GC012F in the United States for the treatment of refractory systemic lupus erythematosus (rSLE).

Key Points: 
  • “We are excited to expand the clinical development of our lead FasTCAR asset, GC012F, for treatment of rSLE in the United States,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell.
  • “This progress marks the second U.S. IND clearance for GC012F, a notable milestone.
  • Systemic lupus erythematosus (SLE) is a B-cell-mediated autoimmune disease, in which autoantibodies produced by the immune system attack the patient’s own tissues, causing multi-organ damage.
  • Further, in preclinical studies, GC012F has shown a more effective elimination of antibody secreting cells compared to CD19 single-targeted CAR-T therapy.

Harpoon Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 9, 2023
Harpoon, SAN, PIPE, Therapy, Carcinoma, ASH, CRS, Cove, Exercise, ESMO, Patient, Research, Prostate cancer, AbbVie, DLL3, G&A, IMS, ORR, Development, RRMM, R, Oncology, BCMA, Society, NEPC, Cytokine release syndrome, Pharmaceutical industry, Cryptocurrency, Security (finance), Rare-earth element, SCLC

SOUTH SAN FRANCISCO, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (NASDAQ: HARP) (the “Company”), a clinical-stage immunotherapy company developing novel T cell engagers, today reported financial results for the third quarter ended September 30, 2023 and provided corporate updates.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (NASDAQ: HARP) (the “Company”), a clinical-stage immunotherapy company developing novel T cell engagers, today reported financial results for the third quarter ended September 30, 2023 and provided corporate updates.
  • Harpoon ended the third quarter of 2023 with $31.6 million in cash, cash equivalents, short-term marketable securities, compared to $53.1 million as of December 31, 2022.
  • Revenue for the third quarter ended September 30, 2023 was $4.5 million, compared to $13.6 million for the third quarter ended September 30, 2022.
  • Research and development (R&D) expense for the third quarter ended September 30, 2023 was $12.3 million, compared to $21.0 million for the third quarter ended September 30, 2022.

Bristol Myers Squibb Announces Data at ASH 2023 from Diverse Multiple Myeloma Pipeline, Underscoring Range of Tailored Treatment Approaches to Address Unique Patient Needs

Retrieved on: 
Tuesday, December 12, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Dexamethasone, ASH, CRS, Patient, Cell, Infection, Bortezomib, B-cell maturation antigen, GPRC5D, Carfilzomib, Therapy, Bristol Myers Squibb, ORR, Cancer, Diagnosis, Anemia, International Myeloma Foundation, CD3, Cytokine release syndrome, Haematopoietic system, Multiple myeloma, Immunomodulatory imide drug, Safety, Immune system, Incidence, Aes, DOR, Science, Hook effect, Public, Drug discovery, Society, Estate (law), Lenalidomide, Proteasome inhibitor, Thrombocytopenia, PFS, BMY, Daratumumab, Neutropenia, Partnership, Skin, Life, Mezi proudy, Research, NYSE, Disease, MRD, Translational Genomics Research Institute, TCE, Survival, BMS, BCMA, Biology, Pharmaceutical industry, Vaccine, Fine chemical, Cohort, RRMM

Bristol Myers Squibb (NYSE: BMY) today announced updated results from three key programs within its broad multiple myeloma research pipeline, highlighting its diverse targets and molecular approaches to address unique patient needs within the disease.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced updated results from three key programs within its broad multiple myeloma research pipeline, highlighting its diverse targets and molecular approaches to address unique patient needs within the disease.
  • These data were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, California.
  • While multiple myeloma remains a relentless disease, we continue to transform the multiple myeloma treatment paradigm by dramatically improving outcomes for every patient.
  • As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma

Retrieved on: 
Friday, December 8, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Multiple myeloma, Lymphocytopenia, Fever, Bispecific monoclonal antibody, NYSE, Cytokine release syndrome, PFE, European Medicines Agency, Rash, European Commission, Pneumonia, Upper respiratory tract infection, CRS, Risk, Febrile neutropenia, Fatigue, EMA, Civil service commission, Patient, Sepsis, Thrombocytopenia, Probability, Periodic breathing, Appetite, CHMP, B-cell maturation antigen, Injection site reaction, Committee, Neutropenia, Diarrhea, Nausea, Arthralgia, RRMM, Anemia, BCMA, Immunotherapy, Hypokalemia, Urinary tract infection, Inc., HIV disease progression rates, Vaccine, Pharmaceutical industry, Pfizer, Nature Medicine

Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab).

Key Points: 
  • Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab).
  • "More than 50,000 Europeans are diagnosed with multiple myeloma each year, and too often, they face relapse and treatment resistance,” said Chris Boshoff, Chief Oncology Research and Development Officer and Executive Vice President, Pfizer.
  • The conditional marketing authorization for ELREXFIO is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway.
  • This authorization follows the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation for a conditional marketing authorization on October 12, 2023.

Bristol Myers Squibb and 2seventy bio Provide Update on U.S. FDA Review of sBLA for Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Monday, November 20, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Oncology Drug Advisory Committee, NYSE, Safety, Food, European Medicines Agency, Progression-free survival, ASH, Risk, Patient, PFS, BMY, ODAC, Exposition, Death, RRMM, Society, PDUFA, OS, HIV disease progression rates, Pharmaceutical industry, Swissmedic, Idecabtagene vicleucel

The date of the ODAC meeting has not yet been confirmed by the FDA.

Key Points: 
  • The date of the ODAC meeting has not yet been confirmed by the FDA.
  • The FDA also informed the companies that a decision on the application will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.
  • The companies anticipate that the committee will review data related to the secondary endpoint of overall survival (OS).
  • The ODAC meeting has no impact on the currently approved indication for Abecma for adult patients with triple-class exposed RRMM after four or more prior lines of therapy.

IASO Bio and Innovent Present New Data of FUCASO® (Equecabtagene Autoleucel) for Multiple Myeloma Patients in Oral Presentation at ASH 2023

Retrieved on: 
Monday, December 11, 2023
Huachung University, Multiple myeloma, Triple, Ophthalmology, HKEX, Safety, SAN, Hope, Treatment, Progression-free survival, ASH, Risk, Tongji Hospital station, Tongji Medical College, Patient, PFS, MRD, Marketing, Trial of the century, Medicine, VCN, Prognosis, Peking Union Medical College, ORR, Cancer, Survival, RRMM, BCMA, Quality of life, Society, Autoimmunity, Pharmaceutical industry, Medical device, Vaccine, Hematology

The presentation highlights the characteristics and efficacy of fully human BCMA-targeting CAR-T (Equecabtagene Autoleucel) on multiple myeloma patients who had sustained minimal residual disease (MRD) negativity after receiving treatment.

Key Points: 
  • The presentation highlights the characteristics and efficacy of fully human BCMA-targeting CAR-T (Equecabtagene Autoleucel) on multiple myeloma patients who had sustained minimal residual disease (MRD) negativity after receiving treatment.
  • As of December 31, 2022, with a median follow-up of 18.07 months, deep and sustained responses were observed in 103 evaluable patients.
  • Among these patients, the overall response rate (ORR) was 96.1%, and the stringent complete response/complete response (sCR/CR) rate was 77.7%.
  • Minimal residual disease (MRD) negativity rate is 94.2% in the total evaluable patients, and all patients who achieved CR or above were MRD negative.

Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Sunday, December 10, 2023
Webcast, Multiple myeloma, Associate, Immunomodulatory imide drug, Safety, SAN, DNA, TSCM, Prodrug, Therapy, Gene, International, CRS, Tissue, Artificial intelligence, SCR, Cytogenetics, Patient, Conference call, Blood, Haemophilia, Conference, Graft-versus-host disease, ORR, TCE, Cancer, Transposase, Partnership, Roche, Malignancy, Antibody, Neurotoxicity, Kinetics, Haemophilia A, RRMM, Cyclophosphamide, BCMA, Physician, Investigator's brochure, Bone marrow, ITT, Vanderbilt-Ingram Cancer Center, Cytokine release syndrome, Vaccine, Pharmaceutical industry, Broadcasting, Hematology

The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM).

Key Points: 
  • The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM).
  • We are excited to have taken this first step with our early P-BCMA-ALLO1 clinical results.
  • They inspire us to further develop P-BCMA-ALLO1 in partnership with Roche, and to continue advancing our entire allogeneic TSCM cell-based CAR-T portfolio."
  • Title: Early Safety Results of P-BCMA-ALLO1, a Fully Allogeneic Chimeric Antigen Receptor T-Cell (CAR-T), in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
    Session Title: 704.

Pfizer Highlights Scientific Advances from Growing Hematology Portfolio at American Society of Hematology Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Bispecific monoclonal antibody, Science, FDA, NYSE, Food, Multiple myeloma, Haemophilia, Bone marrow, SCD, Hematology, B-cell maturation antigen, Safety, Phase 3, Sickle cell disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research, Society, ASH, RRMM, Caregiver, Inc., Health equity, Abstract, PFE, Patient, BCMA, Joint Planning and Development Office, Pharmaceutical industry, Pfizer

Pfizer Inc. (NYSE: PFE) will present its latest data showcasing advances in the treatment of hemophilia, sickle cell disease, and blood cancers at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from December 9-12.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) will present its latest data showcasing advances in the treatment of hemophilia, sickle cell disease, and blood cancers at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from December 9-12.
  • “Pfizer has been advancing science in hematology for more than 30 years, starting with the introduction of recombinant factor replacement therapy, which became the standard of care for people living with hemophilia.
  • Fourteen abstracts focused on the treatment of SCD, including Phase 2a safety, efficacy, and pharmacodynamic data from the ongoing Phase 2/3 clinical trial study of GBT601.
  • Nineteen abstracts from our blood cancer portfolio, including six which continue to support the use of ELREXFIO, a B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody immunotherapy, in patients with RRMM.

Florida Cancer Specialists & Research Institute Launches Advanced Cellular Therapy Program to Treat Recurring Blood Cancers

Retrieved on: 
Tuesday, October 31, 2023
Patient, Bispecific monoclonal antibody, CD3, Multiple myeloma, Food, Therapy, Hope, Bone marrow, BCPS, News, Infection, Teclistamab, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Maintenance, RRMM, Quality of life, Disease, Immune system, Doctor of Pharmacy, Cancer, FCS, Nursing, Pharmaceutical industry, Vaccine, Hospital, MD

FORT MYERS, Fla., Oct. 31, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) is now offering an advanced maintenance therapy program that slows the progression of relapsed/refractory multiple myeloma (RRMM). The treatment, teclistamab (TECVAYLI®), is a type of rapidly evolving cancer therapy that uses the body's immune system to fight cancer. FCS is the first oncology care provider in Sarasota County to offer the maintenance program, with plans to expand to other FCS sites across Florida in the coming months.

Key Points: 
  • FORT MYERS, Fla., Oct. 31, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) is now offering an advanced maintenance therapy program that slows the progression of relapsed/refractory multiple myeloma (RRMM).
  • The treatment, teclistamab (TECVAYLI®), is a type of rapidly evolving cancer therapy that uses the body's immune system to fight cancer.
  • In clinical research trials, 62 percent of patients had a favorable response to this therapy."
  • These therapies work by binding to special proteins that allow the immune system to recognize and kill cancer cells.

Harpoon Therapeutics Presents HPN217 Interim Phase 1 Data at the IMS Annual Meeting

Retrieved on: 
Thursday, September 28, 2023
Index, CRS, B-cell maturation antigen, Patient, SAN, IMS, MTD, Poster, RRMM, Therapy, BCMA, Vaccine, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, today announced the presentation of interim data for the 2.15 to 12 mg target dose cohorts from its Phase 1 clinical trial evaluating single-agent HPN217 in relapsed/refractory multiple myeloma (RRMM). HPN217 targets B-cell maturation antigen (BCMA) and is based on Harpoon’s proprietary Tri-specific T cell Activating Construct (TriTAC®) platform designed to recruit a patient’s immune cells to kill tumor cells. The data will be presented at the 20th International Myeloma Society (IMS) Annual Meeting in a poster presentation on September 28, 2023 in Athens, Greece.

Key Points: 
  • The data will be presented at the 20th International Myeloma Society (IMS) Annual Meeting in a poster presentation on September 28, 2023 in Athens, Greece.
  • As of the data cut-off on August 12, 2023, 97 patients were treated with HPN217 across 14 dose escalation cohorts.
  • The trial enrolled heavily pre-treated patients, of whom 65% were penta-drug exposed and 20% had been treated with BCMA-targeted agents.
  • For more details about the IMS Annual Meeting, please visit: